Medex TranStar ICP Pressure Monitoring Device Recalled Due to Manufacturing Defect
Smiths Medical is recalling the medex TranStar Single ICP Set because a manufacturing defect may cause inaccurate pressure monitoring, monitoring interruptions, or inability to zero the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for a manufacturing defect in a critical intracranial pressure monitoring device that could cause inaccurate monitoring or device malfunction. However, the source reports no illnesses or injuries, placing it in the high-risk category without yet-reported harm.
Plain-English summary
The medex TranStar Single ICP Set, a pressure monitoring device for intracranial measurements (product code REF MX20897), is being recalled by Smiths Medical ASD, Inc., due to a manufacturing defect in the TranStar Disposable Pressure Transducer or the chip within it.
Due to the defect, users may experience inaccurate pressure monitoring, interruption in pressure monitoring, or inability to zero the device. The defect may cause a leak within the pressure transducer or a malfunction within the transducer chip.
The recalled devices were distributed worldwide. Lot number 4323116 is affected, with product identifiers UDI/DI 50351688508551 (case) and 10351688508553 (pouch). Healthcare facilities using this device should immediately discontinue use and contact Smiths Medical ASD, Inc., or the FDA for further instructions.
The recalled product
- Product
- medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- monitoring-defect
- device-malfunction
- transducer-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 50351688508551 (case)
- 10351688508553 (pouch)
- Lot Numbers: 4323116
Distribution
Distribution scope not specified by the agency.
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